Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation (MIEICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01424202
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : August 26, 2011
Information provided by (Responsible Party):
Miguel R. Goncalves, Hospital Sao Joao

Brief Summary:

Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV.

In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.

Condition or disease Intervention/treatment Phase
Post-extubation Failure Persistent Weaning Failure Secretion Encumbrance Weak Cough Ventilatory Failure Device: Mechanical Insufflation Exsufflation Not Applicable

Detailed Description:

Patients under mechanical ventilation (MV) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (SBT) were randomly allocated before extubation, either for (A) conventional extubation protocol (control group) or (B) MI-E extubation protocol (study group). Re-intubation rates, ICU length of stay and NIV failure rates were analyzed.

Inclusion of MI-E in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation ICU length of stay. This technique seems to be efficient in improving the efficacy of NIV in this patient population.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation
Study Start Date : September 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group B
Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications plus daily sessions of mechanical in-exsufflation (MI-E).
Device: Mechanical Insufflation Exsufflation

After passing the SBT and randomized to group B, before extubation, all patients were submitted to a treatment of MI-E (3 sessions) through the endotracheal tube with pressures set at 40 cm H2O for insufflation and -40 cm H2O for exsufflation pressure. An insufflation/exsufflation time ratio of 3secs/2 secs and a pause of 3 sec between each cycle was used. Eight cycles were applied in every session with an abdominal thrust timed to the exsufflation cycle.

On top of the standard medical therapy, during the first 48 hours post extubation, each patient received 3 daily treatments by means of a light-weight, elastic oronasal mask. Treatments (3 sessions each) were divided between morning, afternoon and night, making a total of 9 daily sessions.

The daily treatment frequency and its outcomes were recorded in a diary by the nursing staff. All MI-E treatments were administered by a trained respiratory therapist, ICU physician or nurse.

No Intervention: Group A
Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications.

Primary Outcome Measures :
  1. re-intubation rates [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. NIV failure rates [ Time Frame: 48 hours ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients older than 18 years and under mechanical ventilation, for more than 48 hours, for acute hypoxemic and/or hypercapnic respiratory failure from a specific etiology

Exclusion Criteria:

  • facial or cranial trauma, tracheostomy, active upper gastrointestinal bleeding, neurologic instability (inability to respond to direct simple orders), hemodynamic instability, lack of cooperation and confirmed diagnosis of neuromuscular disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01424202

Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João
Porto, Portugal, 4200-319
Sponsors and Collaborators
Hospital Sao Joao

Publications of Results:
Responsible Party: Miguel R. Goncalves, Professor, Hospital Sao Joao Identifier: NCT01424202     History of Changes
Other Study ID Numbers: MIEICU-08112010
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Miguel R. Goncalves, Hospital Sao Joao:
Post extubation failure
Mechanical Insufflation-Exsufflation
Noninvasive Ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms